System and Device for Reducing Microbial Burden on a Surface

Several embodiments of the present disclosure relate generally to the art of generating atmospheres having sterilizing, disinfecting, sanitizing, decontaminating, and/or therapeutic aspects, and more particularly to sterilization, disinfection, sanitization, and/or decontamination of therapeutic devices, as well as related systems and methods.

Sterilization, disinfection, sanitization, and decontamination methods are used in a broad range of applications. A variety of methods is used, including steam, chemicals, fumigants, radiation, among others. Drawbacks to these methods exist and are addressed by the systems and methods disclosed herein.

As disclosed herein, a variety of items or surfaces may require processing in order to reduce the bioburden and decrease risk of infections. For example, critical items (such as surgical instruments, which contact sterile tissue), semi-critical items (such as endoscopes, which contact mucous membranes), and noncritical items (such as stethoscopes, which contact only intact skin) require various types of treatment, for example sterilization, high-level disinfection, and low-level disinfection, respectively. The present disclosure provides for various systems and methods for disinfecting/sanitizing various items (e.g., medical devices or electronics) and surfaces (e.g., workspaces, patient rooms, organic material, including but not limited to patient wounds).

Various systems and methods are provided for herein in order to accomplish disinfection of one or more items, surfaces etc. Additionally, in several embodiments the systems and methods are configured to allow low- or high-level disinfection. In still additional embodiments, the systems and methods are configured to allow sterilization.

For example, provided for herein in several embodiments is a system for reducing the viability of microorganisms on a surface. In some embodiments, the disclosed system includes a housing including a front panel and a rear panel. In some embodiments, the system includes a filter holder positioned within the front panel, the filter holder including a first opening and a second opening for receiving an inlet filter and an exhaust filter. In some embodiments, the system includes a chamber configured to receive an item to be disinfected, sterilized, or sanitized. In some embodiments, the system includes a cartridge engagement mechanism configured to receive a removable cartridge containing a volume of disinfectant/sterilant. In some embodiments, the system includes an ozone generation system with a duct comprising an inlet and an outlet and an ozone generator positioned along the length of the duct. In some embodiments, the system includes an evaporator with an inlet, an outlet, and a reservoir. In some embodiments, the system includes a nebulizer including an inlet, an outlet, a chamber, a cap. In some embodiments, the nebulizer can convert hydrogen peroxide into a vapor, and is fluidly connected to the reservoir of the evaporator. In some embodiments, the system includes a ducting including a blower, a first pathway configured to receive an airflow from the blower, a second pathway configured to deliver the airflow to the exhaust filter, a third pathway configured to receive the airflow from the inlet filter, and a fourth pathway configured to deliver the airflow to the ozone generation system. In some embodiments, the system includes a vent positioned on the rear panel of the housing, wherein airflow exits the housing through the vent. In some embodiments, the system includes an ambient ozone sensor configured to detect a presence of ozone at a preset threshold value within the airflow, wherein airflow exiting the housing through the vent is configured to first flow past the ambient ozone sensor.

In other embodiments, the system is configured to stop operating if the ambient ozone sensor detects the presence of ozone above the preset threshold value.

In other embodiments, the chamber comprises a base comprising a plurality of inlet openings on a first side of the base and a plurality of outlet openings on a second side of the base. In other embodiments, the plurality of inlet openings in the chamber is configured to receive airflow from the outlet of the evaporator. In other embodiments, the plurality of outlet openings in the chamber is configured to direct airflow to the blower of the ducting. In other embodiments, the chamber includes an inlet panel on a first side of the chamber and an outlet panel on a second side of the chamber. In other embodiments, the inlet panel, and the outlet panel of the chamber each comprise a plurality of openings to allow airflow through the inlet panel and the outlet panel. In other embodiments, the inlet panel, and the outlet panel of the chamber each comprise a plurality of hooks, wherein at least one of the plurality of hooks on the inlet panel and at least one of the corresponding plurality of hooks on the outlet panel are configured to retain at least one wire rack. In other embodiments, at least one wire rack is removable and repositionable by a user. In other embodiments, the outlet panel further includes a filter positioned behind the outlet panel and a filter support to retain the filter to the outlet panel.

In other embodiments, the front panel includes a first door configured to seal the chamber. In other embodiments, the front panel includes a second door configured to allow the user access to the cartridge containing the disinfectant or sterilant. In other embodiments, the front panel includes a third door configured to allow the user access to the filter holder containing the inlet filter and the exhaust filter.

In other embodiments, the inlet filter comprises an activated carbon filter or a high efficiency particulate air (HEPA) filter or both. In other embodiments, the outlet filter comprises an activated carbon filter or a high efficiency particulate air (HEPA) filter or both. In other embodiments, the airflow moves out of the outlet filter and into the housing. In other embodiments, the inlet filter includes an actuator that can be actuated if the inlet filter is not properly positioned or malfunctioning, wherein the exhaust filter comprises an actuator that can be actuated if the outlet filter is not properly positioned of malfunctioning, and wherein the system generates an error message to indicate to a user that at least one of the inlet filter and the exhaust filter is malfunctioning or improperly placed.

In other embodiments, the ozone generator further includes a pair of bars with a pair of electrode centers extending through a pair of glass tubes, wherein each of the pair of electrode centers comprise aluminum. In other embodiments, the pair of bars extend parallel to the length of the duct of the ozone generation system. In other embodiments, the ozone generation system further includes a power supply, wherein the power supply is configured to provide a constant supply of voltage to the ozone generator. In other embodiments, the system generates an error message when the power supply is unable to provide a constant supply of voltage to the ozone generator. In other embodiments, the airflow is moved parallel to the pair of bars of the ozone generator. In other embodiments, the duct of the ozone generation system includes a plurality of fins that are configured to serve as guide vanes to direct airflow and to reduce pressure drops along a length of the duct of the ozone generation system.

In other embodiments, the ozone generation system further includes an ozone sensor wherein the ozone sensor is configured to detect the amount of ozone in the airflow through the ozone generation system and can adjust a duty cycle of the ozone generator to keep the concentration of ozone in the airflow within a preset range. In other embodiments, the ozone sensor can determine the density of air and adjust a duty cycle of the ozone generator.

In other embodiments the reservoir includes a collection point that forms the lowest point of the reservoir. In other embodiments, the collection point can catch excess disinfectant/sterilant. In other embodiments, the excess disinfectant/sterilant of the collection point is configured to flow into the nebulizer. In other embodiments, the reservoir includes an outlet fluidly connected to the inlet of the nebulizer and an inlet fluidly connected to the outlet of the nebulizer.

In other embodiments, the nebulizer includes a predetermined level of disinfectant/sterilant in the chamber. In other embodiments, the system includes a reservoir pump configured to pump disinfectant/sterilant from the collection point of the reservoir to the chamber of the nebulizer. In other embodiments, the system includes a cartridge pump configured to pump disinfectant/sterilant from the cartridge to the chamber. In other embodiments, the cap includes a curved surface that allows excess disinfectant/sterilant to flow back to the chamber of the nebulizer. In other embodiments, the nebulizer includes a pizeocrystal configured to vibrate at a predetermined range to generate a mist of disinfectant/sterilant. In other embodiments, airflow is configured to flow through the inlet of the of the nebulizer, past a portion of the chamber of the nebulizer, and out of the outlet of the nebulizer.

In other embodiments, a first portion of airflow flows into the reservoir of the evaporator and a second portion of airflow flows into the nebulizer. In other embodiments, the first portion is greater than the second portion. In other embodiments, the first portion comprises between 95% to 99.5% of the airflow flowing into the evaporator, and wherein the second portion comprises between 0.5% to 5.0% of the airflow flowing into the evaporator.

In other embodiments, the evaporator includes a central hub, a first pathway, a second pathway, a third pathway, and a valve. In other embodiments, the first pathway can deliver airflow from the inlet to the central hub. In other embodiments, the second pathway can deliver airflow from the central hub, into the reservoir, and out of the outlet. In other embodiments, the third pathway can deliver airflow from the central hub to the outlet. In other embodiments, the valve can be retained within the central hub, wherein the valve is configured to move between a first position and a second position. In other embodiments, the valve rotates 60 degrees between the first position and the second position. In other embodiments, the first position of the valve can allow airflow from the inlet to the reservoir, and out of the outlet. In other embodiments, the second position of the valve is configured to allow airflow from the inlet to the outlet and bypasses the reservoir. In other embodiments, the outlet can direct airflow into the chamber. In other embodiments, the evaporator includes a pad for capturing droplets of disinfectant/sterilant.

In other embodiments, the ducting can include a valve configured to move between a first position and a second position. In other embodiments, the valve can rotate 90 degrees between the first position and the second position. In other embodiments, the first position of the valve can allow airflow from the blower to the ozone generation system. In other embodiments, the second position of the valve can allow airflow from the blower to the exhaust filter and allow airflow from the intake filter In other embodiments, the ducting includes a muffler positioned in the first pathway adjacent to the blower. In other embodiments, the muffler includes muffler foam. In other embodiments, the ducting includes a plurality of fins that can serve as guide vanes to direct airflow and to reduce pressure drops along a length of the duct of the ozone generation system.

In some embodiments, disclosed is a system for reducing the viability of microorganisms on a surface. In some embodiments, the system includes a housing including a front panel and a rear panel. In some embodiments, the system includes an inlet filter and an exhaust filter. In some embodiments, the system includes a chamber includes a base, an inlet panel on a first side of the chamber, an outlet panel on a second side of the chamber, a plurality of inlet openings on a first side of the base, and a plurality of outlet openings on a second side of the base configured to receive an item to be disinfected, sterilized, or sterilized. In some embodiments, the system includes a cartridge containing a volume of disinfectant/sterilant. In some embodiments, the system includes an ozone generation system. In some embodiments, the system includes an evaporator comprising an inlet, an outlet, and a reservoir. In some embodiments, the system includes a nebulizer configured to convert hydrogen peroxide into a vapor, and wherein the nebulizer is fluidly connected to the reservoir of the evaporator. In some embodiments, the system includes a vent positioned on the rear panel of the housing, wherein airflow exits the housing through the vent. In some embodiments, the system includes an ambient ozone sensor configured to detect a presence of ozone at a preset threshold value within the airflow, wherein airflow exiting the housing through the vent is configured to first flow past the ambient ozone sensor.

In other embodiments, the plurality of inlet openings of the chamber can receive airflow from the outlet of the evaporator. In other embodiments, the plurality of outlet openings of the chamber can direct airflow to a blower. In other embodiments, the inlet panel and the outlet panel of the chamber each include a plurality of openings to allow airflow through the inlet panel and the outlet panel. In other embodiments, the inlet panel and the outlet panel of the chamber each comprise a plurality of hooks, wherein at least one of the plurality of hooks on the inlet panel and at least one of the corresponding plurality of hooks on the outlet panel are configured to retain at least one wire rack. In other embodiments, the at least one wire rack of the chamber is removable and repositionable by a user. In other embodiments, the outlet panel of the chamber further comprises a filter positioned behind the outlet panel and a filter support configured to retain the filter to the outlet panel.

In some embodiments, disclosed is a system for reducing the viability of microorganisms on a surface. In some embodiments, the system includes a housing comprising a front panel and a rear panel. In some embodiments, the system includes an inlet filter and an exhaust filter. In some embodiments, the system includes a chamber configured to receive an item to be disinfected, sterilized, or sanitized. In some embodiments, the system includes a cartridge containing a volume of disinfectant/sterilant. In some embodiments, the system includes an ozone generation system including a duct comprising an inlet and an outlet. In some embodiments, the ozone generation system includes an ozone generator positioned along the length of the duct. In some embodiments, the ozone generator includes a pair of bars including a pair of electrode centers extending through a pair of glass tubes, wherein each of the pair of electrode centers comprise aluminum. In some embodiments, the ozone generator includes a power supply configured to provide a constant supply of voltage to the ozone generator. In some embodiments, the system includes an evaporator comprising an inlet, an outlet, and a reservoir. In some embodiments, the system includes a nebulizer configured to convert hydrogen peroxide into a vapor, and wherein the nebulizer is fluidly connected to the reservoir of the evaporator. In some embodiments, the system includes a blower. In some embodiments, the system includes a vent positioned on the rear panel of the housing, wherein airflow exits the housing through the vent. In some embodiments the system includes an ambient ozone sensor configured to detect a presence of ozone at a preset threshold value within the airflow, wherein airflow exiting the housing through the vent is configured to first flow past the ambient ozone sensor.

In other embodiments, the pair of bars of the ozone generator extend parallel to the length of the duct of the ozone generation system. In other embodiments, the system is configured to generate an error message when the power supply of the ozone generator is unable to provide a constant supply of voltage to the ozone generator. In other embodiments, the airflow through the ozone generator is moved parallel to the pair of bars of the ozone generator. In other embodiments, the duct of the ozone generation system includes a plurality of fins that are configured to serve as guide vanes to direct airflow and to reduce pressure drops along a length of the duct of the ozone generation system. In other embodiments, the ozone generation system includes an ozone sensor configured to detect the amount of ozone in the airflow through the ozone generation system and is configured to adjust a duty cycle of the ozone generator to keep the concentration of ozone in the airflow within a preset range. In other embodiments, the ozone sensor is configured to determine the density of air and to adjust a duty cycle of the ozone generator.

In some embodiments, disclosed is a system for reducing the viability of microorganisms on a surface. In some embodiments, the system includes a housing comprising a front panel and a rear panel. In some embodiments, the system includes an inlet filter and an exhaust filter. In some embodiments, the system includes a chamber is configured to receive an item to be disinfected, sterilized, or sanitized. In some embodiments, the system includes a cartridge containing a volume of disinfectant/sterilant. In some embodiments, the system includes an ozone generation system. In some embodiments, the system includes an evaporator comprising an inlet and an outlet. In some embodiments, the evaporate includes a reservoir comprising a collection point forming the lowest point of the reservoir and configured to retain excess disinfectant/sterilant. In some embodiments, the ozone generation system of the system includes a ducting including a central hub, a first pathway configured to deliver airflow from the inlet to the central hub, a second pathway configured to deliver airflow from the central hub, into the reservoir, and out of the outlet, a third pathway configured to deliver airflow from the central hub to the outlet. In some embodiments, the ozone generator includes a valve positioned within the central hub, wherein the valve is configured to move between a first position and a second position. In some embodiments the system includes a nebulizer configured to convert hydrogen peroxide into a vapor, and wherein the nebulizer is fluidly connected to the reservoir of the evaporator. In some embodiments, the system includes a blower. In some embodiments, the system includes a vent positioned on the rear panel of the housing, wherein airflow exits the housing through the vent. In some embodiments, the system includes an ambient ozone sensor to detect a presence of ozone at a preset threshold value within the airflow, wherein airflow exiting the housing through the vent is configured to first flow past the ambient ozone sensor.

In other embodiments, the excess disinfectant/sterilant of the collection point of the reservoir is configured to flow into the nebulizer. In other embodiments, the reservoir of the evaporator comprises an outlet fluidly connected to an inlet of the nebulizer and an inlet fluidly connected to an outlet of the nebulizer. In other embodiments, the evaporator further comprises a pad for capturing droplets of disinfectant/sterilant. In other embodiments, of the air flowing into the evaporator, a first portion of airflow entering the evaporator flows into the reservoir of the evaporator and a second portion of airflow entering the evaporator flows into the nebulizer. In some embodiments, the first portion is greater than the second portion. In some embodiments, the first portion comprises between 95% to 99.5% of the airflow flowing into the evaporator, and wherein the second portion comprises between 0.5% to 5.0% of the airflow flowing into the evaporator. In other embodiments, the valve of the evaporator rotates 60 degrees between the first position and the second position. In some embodiments, the first position of the valve of the evaporator is configured to allow airflow from the inlet to the reservoir, and out of the outlet. In some embodiments, the second position of the valve of the evaporator is configured to allow airflow from the inlet to the outlet and bypasses the reservoir. In other embodiments, the outlet is configured to direct airflow into the chamber.

In some embodiments, disclosed is a system for reducing the viability of microorganisms on a surface. In some embodiments, disclosed is a housing comprising a front panel and a rear panel. In some embodiments, the system includes a housing comprising a front panel and a rear panel. In some embodiments, the systems include amber configured to receive an item to be disinfected, sterilized, or sanitized. In some embodiments, the system includes. a cartridge containing a volume of disinfectant/sterilant. In some embodiments, the system includes an ozone generation system. In some embodiments, disclosed is an evaporator comprising an inlet, an outlet, and a reservoir. In some embodiments, the system includes a nebulizer including an inlet, determined level of disinfectant/sterilant in the chamber. In some embodiments, disclosed is a cap, a piezocrystal configured to vibrate at a predetermined range to generate a mist of disinfectant/sterilant. In some embodiments, the nebulizer of the system is fluidly connected to the reservoir of the evaporator. In some embodiments, the nebulizer of the system is fluidly connected to the reservoir of the evaporator. In some embodiments, the system includes a blower. In some embodiments, the system includes a vent positioned on the rear panel of the housing, wherein airflow exits the housing through the vent. In some embodiments, the system includes an ambient ozone sensor configured to detect a presence of ozone at a preset threshold value within the airflow, wherein airflow exiting the housing through the vent first flows past the ambient ozone sensor.

In other embodiments, the nebulizer is fluidly connected to a reservoir pump configured to pump disinfectant/sterilant from the collection point of the reservoir to the chamber of the nebulizer. In other embodiments, the nebulizer is fluidly connected to a cartridge pump configured to pump disinfectant/sterilant from the cartridge to the chamber. In other embodiments, the cap of the nebulizer includes a curved surface that allows excess disinfectant/sterilant to flow back to the chamber of the nebulizer.

In other embodiments, airflow through the nebulizer flows through the inlet of the of the nebulizer, past a portion of the chamber of the nebulizer, and out of the outlet of the nebulizer. In some embodiments, a first portion of airflow flowing through the evaporator flows into the reservoir of the evaporator and a second portion of airflow flows into the nebulizer. In some embodiments, the first portion is greater than the second portion. In some embodiments, the first portion comprises between 95% to 99.5% of the airflow flowing into the evaporator, and wherein the second portion comprises between 0.5% to 5.0% of the airflow flowing into the evaporator.

In some embodiments, a method for reducing viable microbial burden on a surface is disclosed, the method comprising placing at least one item into a chamber of a system for reducing microorganism viability, wherein the system comprises a nebulizer configured to convert hydrogen peroxide solution into a vapor, a cartridge configured to contain the hydrogen peroxide solution, at least one peristaltic pump, an ozone generator, a blower, an inlet and an outlet. In some embodiments, the method includes activating a conditioning phase to circulate ozone from the ozone generator in the system, wherein the ozone is configured to convert HO molecules to OH radicals so as to reduce residual moisture in the system. In some embodiments, the method includes activating a disinfection phase wherein the hydrogen peroxide solution is nebulized into a spray and is circulated through the system. In some embodiments, the method includes activating a post-disinfection conditioning phase to circulate ozone from the ozone generator in the system, wherein the ozone is configured to neutralize any remaining HOin the system. In some embodiments, the method includes activating a system clearing phase to pull air into the system through the inlet, circulate the air through the nebulizer and the chamber, and exhaust the air out of the outlet.

In some embodiments, the method includes a disinfection phase that operates at an ambient temperature between about 20° C. to 25° C. In some embodiments, the system of the disclosed method operates with an ambient relative humidity between about 20% and 60%. In some embodiments, the method includes conditioning phase that with a duration of at least 2.5 minutes. In some embodiments, the method includes a disinfection phase with a duration of at least 4.5 minutes. In some embodiments, the method includes a post-disinfection phase with a duration of at least 2 minutes. In some embodiments, the method includes a system clearing phase with a duration of at least 1 minute. In some embodiments, the system of the method does not include a heater configured to dry the system. In some embodiments, the system of the disclosed method does not include a humidifier or a dehumidifier. In some embodiments, the system of the disclosed method does not include a desiccator. In some embodiments, the fluid flow during the conditioning phase of the disclosed method circulates fluid flow that bypasses the nebulizer. In some embodiments, fluid flow during the disinfection phase of the disclosed method circulates fluid flow through the nebulizer. In some embodiments, fluid flow during the post-disinfection conditioning phase of the disclosed method circulates fluid flow through the nebulizer. In some embodiments, the fluid flow during the clearing phase of the disclosed method circulates fluid flow that bypasses the nebulizer.

In some embodiments, disclosed is a method for reducing viable microbial burden on a surface. In some embodiments the method includes placing at least one item into a chamber configured to contain the at least one item. In some embodiments, the method includes activating a conditioning phase. In some embodiments, the conditioning phase can include activating a fan to circulate air in a closed loop to circulate the chamber, activating an ozone generator to generate ozone, activating the fan to circulate air, including the ozone, in the closed loop between the ozone generator and the chamber. In some embodiments, the method can include activating a disinfection phase. In some embodiments, the disinfection phase can include pumping disinfectant with a peristaltic pump from a reservoir to a nebulizer, converting disinfectant into a vapor with the nebulizer, activating the fan to circulate air, including the vapor, in the closed loop between the nebulizer and the chamber, and activating the fan to circulate air, including the ozone, in the closed loop between the ozone generator and the chamber. In some embodiments, the method includes activating a post-disinfection conditioning phase. In some embodiments, the post-disinfection conditioning phase includes activating an ozone generator to generate ozone and activating the fan to circulate air, including the ozone, in the closed loop between the ozone generator, the nebulizer, and the chamber. In some embodiments, the method includes activating a system clearing phase. In some embodiments, the system clearing phase includes activating a valve to allow air to flow into the system through an inlet, activating a valve to allow air to flow out of the system through an outlet, and activating the fan to introduce the air through the inlet, into the chamber, and exhaust through the outlet.

In some embodiments, the method includes a temperature conditioning step. In some embodiments, the temperature conditioning step occurs during the purge phase. In some embodiments, the temperature conditioning step occurs during a second or any subsequent purge phase. In some embodiments, the temperature conditioning step can include activating a heating element to increase the temperature of the walls. In some embodiments, the heating element can comprise ductile heating wires. In some embodiments, the heating element can heat a carrier, like air, and a fan to circulate the air throughout the system. In some embodiments, the temperature conditioning increases the temperature of the walls sufficient to remove, for example, hydrogen peroxide from the inner chamber walls and other parts of the system.

In some embodiments, the method is performed in about 10 minutes. In some embodiments, the conditioning phase of the method is about 150 seconds in duration. In some embodiments, the post-disinfection conditioning phase of the method is about 2 minutes in duration. In some embodiments, the sterilization or disinfection phase of the method is about 4 minutes and 30 seconds to about 5 minutes in duration. In some embodiments, the system clearing phase of the method is about 60 seconds. In some embodiments, the system of the method includes an inlet that comprises a HEPA filter. In some embodiments the system clearing phase of the method further comprises closing a valve to allow the fan to push air through the outlet. In some embodiments, the system of the method includes an outlet that comprises an activated carbon filter and a high efficiency particulate air (HEPA) filter. In some embodiments, the method includes disinfectant at a concentration of between about 30% to 60%. In some embodiments, the method includes disinfectant at a concentration of about 50%. In some embodiments, the method includes disinfectant that is hydrogen peroxide. In some embodiments, the method includes hydrogen peroxide at a concentration of about 50%. In some embodiments, the method includes a reservoir with a replaceable cartridge. In some embodiments, the method is operated at a temperature between about 20° C. to 25° C. In some embodiments, the method is operated at a relative humidity between about 20% and 60%. In some embodiments, the method is operated at or below an ambient pressure. In some embodiments, the elevated temperature during the purge phase is performed in about 60 seconds.

In some embodiments, disclosed is an automated method for sterilizing or disinfecting at least one item. In some embodiments, the method includes receiving at least one item to be sterilized or disinfected into an interior volume of a chamber for sterilization or disinfection. In some embodiments, the chamber for sterilization or disinfection is part of a system comprising an inlet, an outlet port, an ozone generator, a sterilant generator, and a plurality of conduits configured to fluidly connect each of the inlet, sterilant generator, ozone generator, and the chamber. In some embodiments, the system includes at least one fan, configured to provide gaseous flow through the system. In some embodiments, the system includes a controller and a plurality of valves in respective conduits. In some embodiments, the method includes activating a conditioning phase by the controller, wherein the conditioning phase is configured to dry a surface of the at least one item in the chamber and internal flow conduits, wherein the controller activates the fan to move air, and wherein the valves are positioned by the controller to provide closed loop flow of air moved by the fan. In some embodiments, the method includes activating an disinfection phase by the controller, wherein the exposure phase is configured to disinfect the at least one item, wherein the controller causes the disinfectant generator to begin generating disinfectant, wherein the disinfectant comprises a mist of hydrogen peroxide generated from a solution of hydrogen peroxide in the disinfectant generator at a concentration of about 50%, wherein the valves are positioned by the controller to provide closed loop flow through the nebulizer so that disinfectant is delivered to the chamber for a pre-determined time to disinfect the at least one item. In some embodiments, the method includes activating a post-disinfection conditioning phase by the controller, wherein the post-disinfection phase introduces ozone generated by the ozone generator into the chamber containing residual hydrogen peroxide disinfectant to neutralize the disinfectant. In some embodiments, the method includes activating a system clearing phase by the controller, wherein the purge phase includes positioning the valves by the controller to allow open flow and to allow air to be pulled in through the inlet and force the gaseous water vapor and oxygen from the chamber and out the outlet, wherein each of the inlet and outlet comprise a respective filter.

In some embodiments, the automated method includes a controller that activates the fan to move air through the ozone generator to produce ozone. In some embodiments, the automated method includes a disinfectant comprising a vapor of hydrogen peroxide. In some embodiments, the automated method operates at a pre-programmed relative ambient humidity between about 20% to 60%. In some embodiments, the conditioning phase of the automated method is activated for about 180 seconds. In some embodiments, the disinfection phase of the automated method is activated for about 4 minutes and 30 seconds. In some embodiments, the post-disinfection conditioning phase of the automated method is activated for about 120 seconds. In some embodiments, the system clearing phase of the automated method is activated for about 60 seconds. In some embodiments, the system of the automated method is configured to receive a cartridge. In some embodiments, the automated method operates between an ambient temperature between about 20° C. to 25° C. In some embodiments, the sterilant of the automated method is delivered by a peristaltic pump. In some embodiments, in the automated method, at least one of the filters of the inlet and outlet is a HEPA filter. In some embodiments, in the automated method, at least one of the filters of the inlet and outlet is a charcoal filter.

Sterilization, disinfection, sanitization, and decontamination methods are used in a broad range of applications, and have used an equally broad range of sterilization, disinfection, sanitization, and decontamination agents. The term “sterilization” generally refers to the inactivation of bio-contamination, especially on inanimate objects. The term “disinfection” generally refers to the inactivation of organisms considered pathogenic. Although the term “sterilization” may be used in describing certain embodiments herein, it would be appreciated that, unless otherwise indicated, such embodiments can also be used for disinfection (e.g., high-level disinfection, low-level disinfection, etc.), sanitization, and/or other types of decontamination, e.g., as provided with their regulatory definitions.

Pulsed or silent electric discharge in air or other gases produces non-thermal plasma. Non-thermal plasma processing involves producing plasma in which the majority of the electrical energy goes into the excitation of electrons. These plasmas are characterized by electrons with kinetic energies much higher than those of the ions or molecules. The electrons in these plasmas are short-lived under atmospheric pressure; instead, they undergo collisions with the preponderant gas molecules. The electron impact on gas molecules causes dissociation and ionization of these molecules, which creates a mix of reactive species, in the form of free radicals, reactive oxygen and nitrogen species, ions, and secondary electrons. These reactive species cause unique and diverse chemical reactions to occur, even at relatively low temperatures. These chemical reactions are utilized in low temperature decontamination and sterilization technologies. While there are certain non-thermal plasma devices for wound treatment (or disinfection, sterilization, etc. of devices and objects), prior to the embodiments disclosed herein, all suffered from various therapeutic and practical limitations. First, all of these devices require interaction between the plasma and the wound (or object); that is, since the electric discharge takes place directly on the tissue, the treated tissue itself plays the role of an electrode. This makes the application of non-thermal plasma exquisitely sensitive to small movements or changes in geometry. This adds significant complexity to the treatment and requires the provider to have specialized training to maintain the proper tolerances. Other limitations include the inability to cover large surface areas in a short period of time and equipment that has a large environmental footprint and requires a high upfront cost. Additionally, current commercialized non-thermal plasma devices have a requirement for significant provider training and time to administer treatment including one on one provider to patient care.

As discussed in detail herein, vaporized hydrogen peroxide (VHP) can be used for sterilization. Certain methods of sterilization with VHP include open loop systems, in which the VHP is applied to the items to be sterilized and then exhausted, and closed loop systems, where sterilizing vapors are recirculated.

In closed loop systems, a carrier gas, such as air, is dried and heated prior to flowing past a vaporizer. A hydrogen peroxide aqueous solution is introduced into the vaporizer and which enables this solution to be vaporized. The resulting vapor is then combined with the carrier gas and introduced into a sterilization chamber of varying size, shape, and material. A blower exhausts the carrier gas from the sterilization chamber and recirculates the carrier gas to the vaporizer where additional VHP is added. Between the sterilization chamber and the vaporizer, the recirculating carrier gas passes through a catalytic destroyer (where any remaining VHP is eliminated from the carrier gas), a dryer, a filter, and a heater.

United States Patent Application Publication No: US 2005/0129571 A1 by Centanni discloses a closed loop sterilization system. The purpose of using the closed loop is to prevent decrease of the free radical concentration in the circulating effluent. Centanni teaches that there should be a VHP (vapor hydrogen peroxide) destroyer employed in the loop. Centanni teaches that the ozone is mixed with the hydrogen peroxide vapor or microdroplets and the vapor or microdroplets are produced by injecting hydrogen peroxide water solution on a hot plate and thus evaporating it.

As discussed in greater detail herein the present application provides for various systems and related methods for sterilizing, disinfecting, sanitizing, and/or decontaminating a variety of items, ranging from surgical equipment or other medical devices to electronic equipment, as well as services, rooms, and other items including, but not limited to soft goods, foods, and related manufacturing equipment. A general overview will be provided, with additional detail related to each of the components of such systems provided below. As mentioned above, the term “sterilization” shall be appreciated to not only encompass the removal of all or substantially all microorganisms and or other pathogens from an object or surface but shall also encompass (unless otherwise specified) disinfection, sanitizing, and decontamination.

The present application discusses concepts relating to removing and/or reducing the presence of viable microorganisms on a surface. This discussion is intended to cover concepts of sterilization, disinfection, sanitization, and decontamination. Decontamination is generally defined as killing some bacteria and fungi while deactivating viruses. Disinfection and sanitization are two levels of decontamination; “disinfection” refers to killing nearly 100% of germs on surfaces or objects while “sanitization” refers to lowering the number of microorganisms to a safe level by either cleaning or disinfecting. Sterilization, on the other hand, refers to the killing of all microorganisms, viruses, and bacterial spores. Each of these concepts refer to a different level of removing and/or reducing the viability of microorganisms on a surface. Unless specified otherwise, reference to a system or method for removing and/or reducing the presence of microorganisms on a surface is intended to encompass all level of reducing microbial burden/viability (e.g., disinfection, sanitization, decontamination, and sterilization).

The prevention of acquired infections, whether in a commercial, home, or healthcare setting, is an important concern. This can be particularly difficult during a viral outbreak when frequently used items must be regularly disinfected, sterilized, and/or sanitized to prevent spread the spread of the virus. Existing methods of disinfection, sterilization, and/or sanitization are inadequate or burdensome. For example, disinfectant wipes can be ineffective if contact time is insufficiently long, or proper protocols are not followed. As well, seams and irregular surfaces can be difficult to reach using manual methods of disinfection, sterilization, and or sanitization. UV systems may be capital intensive, may not be EPA or FDA registered, and may have difficulty treating resilient organisms such as spores. Harsh chemical can damage devices and the exposure of individuals to chemical disinfectants can cause health risks. Lastly, the use of disposable methods of disinfection, sterilization, and/or sanitization can cause a significant environmental impact.

Disclosed are devices, systems, and methods for reducing microorganisms on a surface. As will be discussed in more detail below, the device for reducing microorganisms on a surface can be a fully automated system that is intended to disinfect hard non-porous surfaces for reusable non-critical medical devices and general-use items used in healthcare facilities. The disclosed device provides for rapid and effective broad-spectrum disinfection of items used in various settings (e.g., patient care settings) that offer consistent disinfection for patients, healthcare workers, and equipment used in those settings. Although discussions of the use of the disclosed device may be focused predominantly on healthcare settings, the disclosed device can be intended for home, commercial, or field use.

In some embodiments, the disclosed device is configured to operate at ambient temperature and ambient pressure conditions in a continuous closed loop flow throughout the disinfection, sterilization, and/or sanitization process.

The device for reducing the viability of microorganisms on a surface includes a chamber for receiving the items for reducing the viability of microorganisms on a surface. In some examples, the device can include a chamber with a plurality of removable shelves on which items for disinfection can be placed.

The device for reducing the viability of microorganisms on a surface can include a 50% hydrogen peroxide as the active ingredient for reducing the viability of microorganisms on a surface. In some embodiments, the 50% hydrogen peroxide is packaged in cartridges that can be removed and replaced from the system when the hydrogen peroxide solution is consumed. In some examples, the hydrogen peroxide can be introduced into the system for reducing microorganisms on a surface using a nebulizer that is configured to convert the hydrogen peroxide solution into a micro-spray that inactivates the microorganisms. In some examples, the system can include an ozone generator that produces ozone to condition the system chamber prior to and after the disinfection, sterilization, and/or sanitization process.

The device for reducing the viability of microorganisms on a surface can be configured such that once the disinfection, sterilization, and/or sanitization is completed, fresh air is automatically introduced into the system through a HEPA filter to flush out the system chamber before the disinfected, sterilized, and/or sanitized items are removed. After the disinfection, sterilization, and/or sanitization process is completed, the air that exits the system chamber can be exhausted through a HEPA and an activated carbon filter to ensure substantially only or only clean air leaves the system.

In some embodiments, the device for reducing the viability of microorganisms on a surface can be a fully integrated system that includes hardware, electronics, and software to operate and monitor the system. The system can be programmed to automatically disinfect, sterilize, and/or sanitize the items placed in the device with the push of a button by the user.

illustrate perspective views of the front and rear of the device for disinfection, sterilization, and/or sanitization. In some embodiments, the device for disinfection, sterilization, and/or sanitizationincludes a housingwith a front paneland a rear panel. In some examples, the front panelof the housingcan include a chamber door, a cartridge door, and a service door. As will be discussed in more detail below, the chamber doorcan be used to open to allow access to the chamber. When closed, the chamber doorcan seal the chamber. In some examples, the cartridge engagement mechanismcan include a windowthat allows items placed in the chamberto be visible to the user. In some embodiments, the cartridge doorcan open to allow access to the cartridge engagement mechanismand the cartridge. When the cartridge dooris disengaged, the user can access the cartridge engagement mechanismto remove and/or replace the cartridgein the cartridge engagement mechanism. In some examples, the service doorcan disengage to allow access to the plurality of filters.

In some embodiments, the service doorcan include a user displayand a plurality of buttons. In some embodiments, the user displaycan provide information regarding the device for disinfection, sterilization, and/or sanitizationto the user. In some examples, the plurality of buttonscan allow the user to interact with the system of the device for disinfection, sterilization, and/or sanitization. For example, the user can begin, alter, and/or end the disinfection, sterilization, and/or sanitization process. In other examples, the user can diagnose problems with the device for disinfection, sterilization, and/or sanitizationand the user displaycan provide the user information to fix any errors identified. In other examples, the user displaycan provide information regarding the device and or the systems for disinfection, sterilization, and/or sterilization. In some embodiments, the user displaycan be configured to provide information to the user on the status of the disinfection, sterilization, and/or sanitization of the items in the chamber.

illustrates the rear panelthat can include an exhaust. In some embodiments, the exhaustforms a recessin the wall of the rear panel. As shown in, a ventof the exhaustcan be positioned on the rear panelsuch that, if the device for disinfection, sterilization, and/or sanitizationis placed against a surface, the ventcan be set away from the wall. In some examples, the rear panelcan include a recessfor a power entry moduleand a power cord recess. As shown in, the power entry moduleis further recessed in the rear panelthan the power cord recess. The arrangement of the recessof the power entry moduleand the power cord recesscan allow a power cordto be engaged with the power entry moduleand wrap around the device while allowing the rear panelto be positioned flush against a wall. In some embodiments, the power cord recesscan extend across the entire length of the rear panelto allow the power cordto be arranged along either side of the device. In some examples, the power entry modulecan include a power jack, a power switch, and a fuse. As mentioned above, the position of the power entry modulein the recessallows the power switch, fuse, and power jackto be set away from a wall if the deviceis set against a wall.

illustrate a front view of the devicewith the front panelremoved. With the front panelremoved, the chamber, the cartridge engagement mechanism, and the filter holderare visible.illustrates the devicewith the cartridgepositioned in the cartridge engagement mechanismand the filters,positioned in the filter holder.illustrates the devicewith the cartridgeremoved from the cartridge engagement mechanismand the filters,removed from the filter holder.